Disclaimer The FDA chose a specific outcome algorithm that met its need for a given medical product-outcome assessment. The use of a specific outcome algorithm in a Sentinel assessment should not be interpreted as an endorsement from FDA to use the algorithm for all safety assessments. Investigators should always consider the objective, study design, analytic approach, and data source of a given medical product safety assessment when choosing the outcome algorithm. The suitability of an outcome algorithm may change when applied to different scenarios. For additional information, please refer to the Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data guidance document provided by the FDA.
Title Description Outcome Algorithm to Define Outcome Overview Complex Regional Pain Syndrome (CRPS), Uveitis, Acute Disseminated Encephalomyelitis (ADEM), and Acute Pericarditis Algorithms Defined in "Sequential Analysis of Gardasil 9 Safety" This report lists International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) and ICD-10-CM diagnosis codes and algorithms used to define complex regional pain syndrome (CRPS), uveitis, acute disseminated encephalomyelitis (ADEM), and acute pericarditis in this request. For additional information about the algorithm and how it was defined relative to the cohort and exposures of interest in the inferential analysis, see the Modular Program reports here: https://www.sentinelinitiative.org/vaccines-bloodbiologics/assessments/sequential-analysis-gardasil-9-safety. CRPS, uveitis, ADEM, and acute pericarditis Outcome 1: Evidence of an ICD-9-CM or ICD-10-CM code used to define CRPS in any care setting (Inpatient, Non-Acute Institutional Stay, Emergency Department, or Other Ambulatory Visit) in any diagnosis position. Outcome 2: Evidence of an ICD-9-CM or ICD-10-CM code used to define uveitis in any care setting (Inpatient, Non-Acute Institutional Stay, Emergency Department, or Other Ambulatory Visit) in any diagnosis position. Outcome 3: Evidence of an ICD-9-CM or ICD-10-CM code used to define ADEM in the Inpatient or Emergency Department care setting in any diagnosis position. Outcome 4: Evidence of an ICD-9-CM or ICD-10-CM code used to define acute pericarditis in the Inpatient care setting in any diagnosis position.
Glossary Care Setting - type of medical encounter or facility where the exposure, event, or condition code was recorded. Possible care settings include: Inpatient Hospital Stay (IP), Non-Acute Institutional Stay (IS), Emergency Department (ED), Ambulatory Visit (AV), and Other Ambulatory Visit (OA). For laboratory results, possible care settings include: Emergency department (E), Home (H), Inpatient (I), Outpatient (O), or Unknown or missing (U) Outcome - outcome of interest (either primary or secondary) Principal Diagnosis (PDX) - diagnosis or condition established to be chiefly responsible for admission of the patient to the hospital. 'P' = principal diagnosis, 'S' = secondary diagnosis, 'X' = unspecified diagnosis, '.' = blank. Along with the Care Setting values, forms the Caresetting/PDX parameter. Query Period - period in which the modular program looks for exposures and outcomes of interest Request Send Date - date the request was sent to Sentinel Data Partners
International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) and ICD-10-CM Diagnosis Codes Used to Define Complex Regional Pain Syndrome (CRPS) in this Request Codes Code Type Description 337.20 ICD-9-CM Reflex sympathetic dystrophy, unspecified 337.21 ICD-9-CM Reflex sympathetic dystrophy of the upper limb 337.22 ICD-9-CM Reflex sympathetic dystrophy of the lower limb 337.29 ICD-9-CM Reflex sympathetic dystrophy of other specified site G90.50 ICD-10-CM Complex regional pain syndrome I, unspecified G90.511 ICD-10-CM Complex regional pain syndrome I of right upper limb G90.512 ICD-10-CM Complex regional pain syndrome I of left upper limb G90.513 ICD-10-CM Complex regional pain syndrome I of upper limb, bilateral G90.519 ICD-10-CM Complex regional pain syndrome I of unspecified upper limb G90.521 ICD-10-CM Complex regional pain syndrome I of right lower limb G90.522 ICD-10-CM Complex regional pain syndrome I of left lower limb G90.523 ICD-10-CM Complex regional pain syndrome I of lower limb, bilateral G90.529 ICD-10-CM Complex regional pain syndrome I of unspecified lower limb G90.59 ICD-10-CM Complex regional pain syndrome I of other specified site
International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) and ICD-10-CM Diagnosis Codes Used to Define Uveitis in this Request Codes Code Type Description 360.11 ICD-9-CM Sympathetic uveitis 363.00 ICD-9-CM Focal chorioretinitis, unspecified 363.01 ICD-9-CM Focal choroiditis and chorioretinitis, juxtapapillary 363.03 ICD-9-CM Focal choroiditis and chorioretinitis of other posterior pole 363.04 ICD-9-CM Focal choroiditis and chorioretinitis, peripheral 363.05 ICD-9-CM Focal retinitis and retinochoroiditis, juxtapapillary 363.06 ICD-9-CM Focal retinitis and retinochoroiditis, macular or paramacular 363.07 ICD-9-CM Focal retinitis and retinochoroiditis of other posterior pole 363.08 ICD-9-CM Focal retinitis and retinochoroiditis, peripheral 363.10 ICD-9-CM Disseminated chorioretinitis, unspecified 363.11 ICD-9-CM Disseminated choroiditis and chorioretinitis, posterior pole 363.12 ICD-9-CM Disseminated choroiditis and chorioretinitis, peripheral 363.13 ICD-9-CM Disseminated choroiditis and chorioretinitis, generalized 363.14 ICD-9-CM Disseminated retinitis and retinochoroiditis, metastatic 363.20 ICD-9-CM Chorioretinitis, unspecified 364.00 ICD-9-CM Acute and subacute iridocyclitis, unspecified 364.01 ICD-9-CM Primary iridocyclitis 364.04 ICD-9-CM Secondary iridocyclitis, noninfectious 364.3 ICD-9-CM Unspecified iridocyclitis H20.00 ICD-10-CM Unspecified acute and subacute iridocyclitis H20.011 ICD-10-CM Primary iridocyclitis, right eye H20.012 ICD-10-CM Primary iridocyclitis, left eye H20.013 ICD-10-CM Primary iridocyclitis, bilateral H20.019 ICD-10-CM Primary iridocyclitis, unspecified eye H20.041 ICD-10-CM Secondary noninfectious iridocyclitis, right eye H20.042 ICD-10-CM Secondary noninfectious iridocyclitis, left eye H20.043 ICD-10-CM Secondary noninfectious iridocyclitis, bilateral H20.049 ICD-10-CM Secondary noninfectious iridocyclitis, unspecified eye H20.9 ICD-10-CM Unspecified iridocyclitis H30.001 ICD-10-CM Unspecified focal chorioretinal inflammation, right eye H30.002 ICD-10-CM Unspecified focal chorioretinal inflammation, left eye H30.003 ICD-10-CM Unspecified focal chorioretinal inflammation, bilateral H30.009 ICD-10-CM Unspecified focal chorioretinal inflammation, unspecified eye H30.011 ICD-10-CM Focal chorioretinal inflammation, juxtapapillary, right eye H30.012 ICD-10-CM Focal chorioretinal inflammation, juxtapapillary, left eye H30.013 ICD-10-CM Focal chorioretinal inflammation, juxtapapillary, bilateral H30.019 ICD-10-CM Focal chorioretinal inflammation, juxtapapillary, unspecified eye H30.021 ICD-10-CM Focal chorioretinal inflammation of posterior pole, right eye H30.022 ICD-10-CM Focal chorioretinal inflammation of posterior pole, left eye H30.023 ICD-10-CM Focal chorioretinal inflammation of posterior pole, bilateral
H30.029 ICD-10-CM Focal chorioretinal inflammation of posterior pole, unspecified eye H30.031 ICD-10-CM Focal chorioretinal inflammation, peripheral, right eye H30.032 ICD-10-CM Focal chorioretinal inflammation, peripheral, left eye H30.033 ICD-10-CM Focal chorioretinal inflammation, peripheral, bilateral H30.039 ICD-10-CM Focal chorioretinal inflammation, peripheral, unspecified eye H30.041 ICD-10-CM Focal chorioretinal inflammation, macular or paramacular, right eye H30.042 ICD-10-CM Focal chorioretinal inflammation, macular or paramacular, left eye H30.043 ICD-10-CM Focal chorioretinal inflammation, macular or paramacular, bilateral H30.049 ICD-10-CM Focal chorioretinal inflammation, macular or paramacular, unspecified eye H30.101 ICD-10-CM Unspecified disseminated chorioretinal inflammation, right eye H30.102 ICD-10-CM Unspecified disseminated chorioretinal inflammation, left eye H30.103 ICD-10-CM Unspecified disseminated chorioretinal inflammation, bilateral H30.109 ICD-10-CM Unspecified disseminated chorioretinal inflammation, unspecified eye H30.111 ICD-10-CM Disseminated chorioretinal inflammation of posterior pole, right eye H30.112 ICD-10-CM Disseminated chorioretinal inflammation of posterior pole, left eye H30.113 ICD-10-CM Disseminated chorioretinal inflammation of posterior pole, bilateral H30.119 ICD-10-CM Disseminated chorioretinal inflammation of posterior pole, unspecified eye H30.121 ICD-10-CM Disseminated chorioretinal inflammation, peripheral right eye H30.122 ICD-10-CM Disseminated chorioretinal inflammation, peripheral, left eye H30.123 ICD-10-CM Disseminated chorioretinal inflammation, peripheral, bilateral H30.129 ICD-10-CM Disseminated chorioretinal inflammation, peripheral, unspecified eye H30.131 ICD-10-CM Disseminated chorioretinal inflammation, generalized, right eye H30.132 ICD-10-CM Disseminated chorioretinal inflammation, generalized, left eye H30.133 ICD-10-CM Disseminated chorioretinal inflammation, generalized, bilateral H30.139 ICD-10-CM Disseminated chorioretinal inflammation, generalized, unspecified eye H30.891 ICD-10-CM Other chorioretinal inflammations, right eye H30.892 ICD-10-CM Other chorioretinal inflammations, left eye H30.893 ICD-10-CM Other chorioretinal inflammations, bilateral H30.899 ICD-10-CM Other chorioretinal inflammations, unspecified eye H30.90 ICD-10-CM Unspecified chorioretinal inflammation, unspecified eye H30.91 ICD-10-CM Unspecified chorioretinal inflammation, right eye H30.92 ICD-10-CM Unspecified chorioretinal inflammation, left eye H30.93 ICD-10-CM Unspecified chorioretinal inflammation, bilateral H44.131 ICD-10-CM Sympathetic uveitis, right eye H44.132 ICD-10-CM Sympathetic uveitis, left eye H44.133 ICD-10-CM Sympathetic uveitis, bilateral H44.139 ICD-10-CM Sympathetic uveitis, unspecified eye
International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) and ICD-10-CM Diagnosis Codes Used to Define Acute Disseminated Encephalomylelitis (ADEM) in this Request Codes Code Type Description 323.51 ICD-9-CM ENCEPHALITIS AND ENCEPHALOMYELITIS FOLLOWING IMMUNIZATION PROCEDURES 323.52 ICD-9-CM MYELITIS FOLLOWING IMMUNIZATION PROCEDURES 323.61 ICD-9-CM INFECTIOUS ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM) 323.62 ICD-9-CM OTHER POSTINFECTIOUS ENCEPHALITIS AND ENCEPHALOMYELITIS 323.81 ICD-9-CM OTHER CAUSES OF ENCEPHALITIS AND ENCEPHALOMYELITIS 323.9 ICD-9-CM UNSPECIFIED CAUSES OF ENCEPHALITIS, MYELITIS, AND ENCEPHALOMYELITIS G04.00 ICD-10-CM Acute disseminated encephalitis and encephalomyelitis, unspecified G04.01 ICD-10-CM Postinfectious acute disseminated encephalitis and encephalomyelitis (postinfectious ADEM) G04.02 ICD-10-CM Postimmunization acute disseminated encephalitis, myelitis and encephalomyelitis G04.30 ICD-10-CM Acute necrotizing hemorrhagic encephalopathy, unspecified G04.31 ICD-10-CM Postinfectious acute necrotizing hemorrhagic encephalopathy G04.32 ICD-10-CM Postimmunization acute necrotizing hemorrhagic encephalopathy G04.39 ICD-10-CM Other acute necrotizing hemorrhagic encephalopathy G04.81 ICD-10-CM Other encephalitis and encephalomyelitis G04.90 ICD-10-CM Encephalitis and encephalomyelitis, unspecified
International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) and ICD-10-CM Diagnosis Codes Used to Define Acute Pericarditis in this Request Codes Code Type Description 074.21 ICD-9-CM Coxsackie pericarditis 420.91 ICD-9-CM Acute idiopathic pericarditis 420.90 ICD-9-CM Acute pericarditis, unspecified 420.99 ICD-9-CM Other acute pericarditis B33.23 ICD-10-CM Viral pericarditis I30.0 ICD-10-CM Acute nonspecific idiopathic pericarditis I30.1 ICD-10-CM Infective pericarditis I30.8 ICD-10-CM Other forms of acute pericarditis I30.9 ICD-10-CM Acute pericarditis, unspecified